Switzerland: new requirements regarding clinical trial insurance

January 1, 2014

According to the Federal Act on Research involving Human Beings (Human Research Act – HRA), starting the 1st of January, 2014, there are 3 categories of clinical trials: A, B and C.

According to Article 13 of the Clinical Trials ordinance – ClinO:

- The liability coverage must cover damage occurring up to ten years after the completion of the clinical trial

- The policy value shall be set as following:

For Category A clinical trials where any measures for the collection of health-related personal data or the sampling of biological material entail more than only minimal risks and burdens, the policy value shall be at least:
a. per person: CHF 250,000
b. for damage to property: CHF 20,000
c. for the entire clinical trial: CHF 3,000,000

For other clinical trials, the policy value shall be at least:
a. per person: CHF 1,000,000
b. for damage to property: CHF 50,000
c. for the entire clinical trial: CHF 10,000,000

For more information:
Swissmedic Website: https://www.swissmedic.ch/bewilligungen/00155/00242/index.html?lang=en

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